FDA approvals

FDA approves once-daily oral sofosbuvir combination as hepatitis C treatment

The FDA today approved once-daily oral nucleotide analog sofosbuvir as part of an antiviral regimen for the treatment of hepatitis C patients with genotypes 1, 2, 3 or 4, according to a news release.

A 12-week course of 400 mg sofosbuvir with ribavirin was approved for adult patients with chronic hepatitis C genotype 2; a 24-week course of sofosbuvir with ribavirin was approved for adult patients with chronic genotype 3; and a 12-week course of sofosbuvir with pegylated interferon and ribavirin was approved for adult patients with genotypes 1 and 4, according to a release from drugmaker Gilead Sciences.

“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said a release from the FDA.

Sofosbuvir’s new drug application was supported by a series of phase 3 studies that demonstrated superiority or noninferiority in achieving sustained virologic response 12 weeks after completing 12 or 16 weeks of sofosbuvir-based therapy.

Gilead, which intends to market sofosbuvir under the trade name Sovaldi, is facing patent infringement and interference lawsuits over the drug filed this month by Idenix Pharmaceuticals.

“It is our hope that Sovaldi will mark the beginning of a new era in hepatitis C treatment,” John C. Martin, PhD, chairman and CEO of Gilead Sciences, said in the company’s release.

Gilead also has marketing approval applications for sofosbuvir pending in the European Union, Australia, Canada, New Zealand, Switzerland and Turkey.

The FDA today approved once-daily oral nucleotide analog sofosbuvir as part of an antiviral regimen for the treatment of hepatitis C patients with genotypes 1, 2, 3 or 4, according to a news release.

A 12-week course of 400 mg sofosbuvir with ribavirin was approved for adult patients with chronic hepatitis C genotype 2; a 24-week course of sofosbuvir with ribavirin was approved for adult patients with chronic genotype 3; and a 12-week course of sofosbuvir with pegylated interferon and ribavirin was approved for adult patients with genotypes 1 and 4, according to a release from drugmaker Gilead Sciences.

“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said a release from the FDA.

Sofosbuvir’s new drug application was supported by a series of phase 3 studies that demonstrated superiority or noninferiority in achieving sustained virologic response 12 weeks after completing 12 or 16 weeks of sofosbuvir-based therapy.

Gilead, which intends to market sofosbuvir under the trade name Sovaldi, is facing patent infringement and interference lawsuits over the drug filed this month by Idenix Pharmaceuticals.

“It is our hope that Sovaldi will mark the beginning of a new era in hepatitis C treatment,” John C. Martin, PhD, chairman and CEO of Gilead Sciences, said in the company’s release.

Gilead also has marketing approval applications for sofosbuvir pending in the European Union, Australia, Canada, New Zealand, Switzerland and Turkey.

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